MYCAMINE 50 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

MICAFUNGIN AS SODIUM

Commercializzato da:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

Codice ATC:

J02AX05

Forma farmaceutica:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composizione:

MICAFUNGIN AS SODIUM 50 MG

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

ASTELLAS IRELAND CO. LTD, IRELAND

Area terapeutica:

MICAFUNGIN

Indicazioni terapeutiche:

Adults, adolescents ≥ 16 years of age and elderly:- Treatment of invasive candidiasis.- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.Children (including neonates) and adolescents < 16 years of age:- Treatment of invasive candidiasis.- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.

Data dell'autorizzazione:

2021-04-30

Foglio illustrativo

ראוד את
11458
:סקפ רפסמ ,ןיעה שאר
03-5366691
:ןופלט רפסמ
03-7501166
21.08.2019
,ה/דבכנ ת/חקור ה/אפור
ננוצרב
אפורל ןולעב ןוכדע לע ךעידוהל ו
MYCAMINE 50 MG POWDER FOR SOLUTION FOR INFUSION.
MYCAMINE 100 MG POWDER FOR SOLUTION FOR INFUSION
.
: ליעפ רמוח
MYCAMINE 50 MG: EACH VIAL CONTAINS 50 MG MICAFUNGIN (AS SODIUM).
MYCAMINE 100 MG: EACH VIAL CONTAINS 100 MG MICAFUNGIN (AS SODIUM). אפורל ןולעב םינוכדע ןלהל
(
ןמוסמ טסקט
קורי
ותועמשמ
ןוכדע
,
)הרמחה ותועמשמ בוהצ ןמוסמ טסקט
:
[…]
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HEPATIC EFFECTS:
THE DEVELOPMENT OF FOCI OF ALTERED HEPATOCYTES (FAH) AND
HEPATOCELLULAR TUMOURS AFTER A TREATMENT PERIOD OF
3 MONTHS OR LONGER WERE OBSERVED IN RATS. THE ASSUMED THRESHOLD FOR
TUMOUR DEVELOPMENT IN RATS IS
APPROXIMATELY IN THE RANGE OF CLINICAL EXPOSURE. THE CLINICAL
RELEVANCE OF THIS FINDING IS NOT KNOWN. LIVER
FUNCTION SHOULD BE CAREFULLY MONITORED DURING MICAFUNGIN TREATMENT. TO
MINIMISE THE RISK OF ADAPTIVE
REGENERATION AND POTENTIALLY SUBSEQUENT LIVER TUMOUR FORMATION, EARLY
DISCONTINUATION IN THE PRESENCE OF
SIGNIFICANT AND PERSISTENT ELEVATION OF ALT/AST IS RECOMMENDED.
MICAFUNGIN TREATMENT SHOULD BE CONDUCTED
ON A CAREFUL RISK/BENEFIT BASIS, PARTICULARLY IN PATIENTS HAVING
SEVERE LIVER FUNCTION IMPAIRMENT OR CHRONIC LIVER
DISEASES KNOWN TO REPRESENT PRENEOPLASTIC CONDITIONS, SUCH AS ADVANCED
LIVER FIBROSIS, CIRRHOSIS, VIRAL HEPATITIS,
NEONATAL LIVER DISEASE OR CONGENITAL ENZYME DEFECTS, OR RECEIVING A
CONCOMITANT THERAPY INCLUDING HEPATOTOXIC
AND/OR GENOTOXIC PROPERTIES.
[…]
4.6
FERTILITY, PREGNANCY AND LACTATION
[…]
4.8
UNDESIRABLE EFFECTS
[…]
SYSTEM ORGAN
ACLASS
COMMON
≥ 1/100 to < 1/10
UNCOMMON
≥ 1/1,000 to < 1/100
RARE
≥ 1/10,000 to
< 1/1,000
NOT KNOWN
(frequency cannot be
estimated from
available data)
Immune system
disorders
anaphylactic / anaphylactoid
reaction (see section 4.4),
hypersensitivity
anaphy

Scheda tecnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Mycamine 50 mg powder for concentrate for solution for infusion.
Mycamine 100 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium).
After reconstitution each ml contains 10 mg micafungin (as sodium).
Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium).
After reconstitution each ml contains 20 mg micafungin (as sodium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White compact powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mycamine is indicated for:
Adults,
adolescents ≥
16 years of age and elderly:
-
Treatment of invasive candidiasis.
-
Treatment of oesophageal candidiasis in patients for whom intravenous
therapy is appropriate.
-
Prophylaxis of _Candida_ infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation.
Children (including neonates) and adolescents < 16 years of age:
-
Treatment of invasive candidiasis.
-
Prophylaxis of _Candida_ infection in patients undergoing allogeneic
haematopoietic stem cell
transplantation.
The decision to use Mycamine should take into account a potential risk
for the development of liver
tumours (see section 4.4). Mycamine should therefore only be used if
other antifungals are not
appropriate.
CONSIDERATION SHOULD BE GIVEN TO OFFICIAL/NATIONAL GUIDANCE ON THE
APPROPRIATE USE OF ANTIFUNGAL
AGENTS.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Mycamine should be initiated by a physician experienced
in the management of fungal
infections.
2
Posology
Specimens for fungal culture and other relevant laboratory studies
(including histopathology) should
be obtained prior to therapy to isolate and identify causative
organism(s). Therapy may be instituted
before the results of the cultures and other laboratory studies are
known. However, once these results
become available, antifungal therapy should be ad